BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE

• K Number: K983498
• Device Name: BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
• Manufacturer: C.R. BARD, INC.
• Date Cleared: 1998-12-15 ( 71 days)
• Product Code: FAD
• Regulation Number: 876.4620

Intended Use

The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

Device Description

The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal.

Predicate Devices

K903345

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical medical device (a ureteral stent) and its materials and intended use. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies focus on physical properties and adherence to existing standards for ureteral stents.

Therapeutic

No.
The primary purpose of the device is to relieve obstruction, which is a structural intervention, not a therapeutic treatment. While it may enhance patient comfort, that is a secondary effect and not its main indication.

Diagnostic

No

This device is a ureteral stent designed to relieve obstruction; it does not diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical polyurethane stent with a coating and suture, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use describes a device used to relieve obstruction in the ureter, which is an internal anatomical structure. This is a therapeutic and interventional use, not a diagnostic one performed on samples outside the body.
• Device Description: The device is a physical stent designed to be placed within the ureter. It does not involve the analysis of biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or diagnostic procedures typically associated with IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a medical device used for treatment within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

Product codes (comma separated list FDA assigned to the subject device)

78 FAD

Device Description

The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ureter

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Bard Lubricious Ureteral Stent referenced in this submission is held to the same design, manufacture, and performance specifications as those stents currently manufactured. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

#K903345

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).

Summary

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K9834498

Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be filled with a solid black color. The font style is blocky and geometric, giving the word a strong and impactful appearance. The letters are evenly spaced and aligned horizontally.

SECTION VI

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

A. Submitter's Information:

Submitter's Name: Address:

Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:

C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Georgia C. Abernathy [phone] [phone] September 30, 1998

• B. Device Name:

| Trade Name: | Bard® InLay™ Lubricious Double Pigtail Ureteral Stent with
Suture |
|----------------------|----------------------------------------------------------------------|
| Common / Usual Name: | Bard Lubricious Ureteral Stent |
| Classification Name: | Ureteral Stent |

• C. Predicate Device Name:
  Bard Lubricious-Coated Ureteral Stent with Suture Trade Name:

• D. Device Description:
  The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal.

• E. Intended Use:
  The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

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• F. Technological Characteristics Summary:

Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bard Lubricious Ureteral Stent versus the predicate device.

| Product Characteristic | Bard Lubricious Ureteral Stent
(this 510(k)) | Bard Lubricious-Coated Ureteral
Stent with Suture
(Predicate device) (#K903345) | Difference |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | Stent | | |
| Indications or Intended
Use | The Bard Lubricious Ureteral Stent is
indicated to relieve obstruction in a
variety of benign, malignant and post-
traumatic conditions in the ureter such as
presence of stones and/or stone
fragments, or other ureteral obstructions
such as those associated with ureteral
stricture, carcinoma of abdominal organs,
retroperitoneal fibrosis or ureteral
trauma, or in association with
Extracorporeal Shock Wave Lithotripsy
(ESWL). The stent may be placed using
endoscopic surgical techniques or
percutaneously using standard
radiographic technique. | The Bard Lubricious-Coated Ureteral
Stent with Suture is indicated to relieve
obstruction in a variety of benign,
malignant and post-traumatic conditions
in the ureter such as presence of stones
and/or stone fragments, or other ureteral
obstructions such as those associated
with ureteral stricture, carcinoma of
abdominal organs, retroperitoneal
fibrosis or ureteral trauma, or in
association with Extracorporeal Shock
Wave Lithotripsy (ESWL). The stent
may be placed using endoscopic surgical
techniques or percutaneously using
standard radiographic technique. | None |
| Disposable | Yes | Yes | None |
| Sterile | Yes | Yes | None |
| Stent Base Material | Polyurethane | Polyurethane | None |
| X-Ray Opaque | Yes | Yes | None |
| Coating
Double Pigtail | Hydrophilic polymer (lubricious)* | Hydrophilic polymer (lubricious) | Different formula,
different supplier |
| Multilength | Hydrophilic polymer (lubricious) | None | Not previously
coated |
| Fr. Sizes Available | 4.7**, 6, 7 and 8 Fr. | 4.7, 6, 7 and 8 Fr. | 4.7 Fr. stent will
have a taper on the
kidney-end tip |
| Double Pigtail Lengths | 14, 20-30cm* | 14-30cm | 16 and 18cm
lengths deleted |
| Multilength Lengths | 22-32cm (one overall adjustable length) | 22-32cm (one overall adjustable length) | None |
| Pigtail Geometry
Double Pigtail | 360° curvature + 45° overlap (both ends) | "J" curl configuration (no overlap) | Additional curl
length |
| Multilength
Suture Loop | Yes-USP Medical Grade black nylon
monofilament; 3-0 | Yes-USP Medical Grade dark blue nylon
monofilament; 3-0 | Color change, both
biocompatible |
| Guidewire Interface | 4.7 Fr. = .035" diameter*
6, 7, 8 Fr. = .038" diameter* | 4.7 Fr. = .025" diameter
6, 7, 8 Fr. = .038" diameter* | 4.7 Fr. interfaces
with larger diameter
guidewire |
| Stent Clamp? | Yes | Yes | None |

Table VI-1
Comparison Summary of Technological Characteristics

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| Product Characteristic | Bard Lubricious Ureteral Stent
(this 510(k)) | Bard Lubricious-Coated Ureteral
Stent with Suture
(Predicate device) (#K903345) | Difference |
|------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Push Catheter | | | |
| Color | Orange* | Green | Color change |
| Material | High Density Polyethylene (HDPE) | High Density Polyethylene (HDPE) | None |
| Guidewire Interface | 4.7 Fr. = .035" diameter*
6, 7/8 Fr. = .038" diameter* | 4.7 Fr. = .025" diameter
6/7/8 Fr. = .038" diameter | 4.7 Fr. interfaces
with larger diameter
guidewire |
| Radiopacity | Radiopaque marker band near distal end* | N/A | Add radiopaque
band |
| Length | 4.7, 6, 7, 8 Fr. = 17.75"* | 4.7 Fr. = 22"
6/7/8 Fr. = 16" | Length changed,
OD on new push
catheter same as
stent |

New feature(s) or change this 510(k) *

• ** 4.7 Fr. stent will have a taper on the kidney-end tip

G. Performance Data Summary:

The Bard Lubricious Ureteral Stent referenced in this submission is held to the same design, manufacture, and performance specifications as those stents currently manufactured. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997.

3

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body. The symbol is rendered in a thick, black line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1998

Georgia C. Abernathy Regulatory Affairs Associate C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209

Re: K983498

Bard® Inlay™ Lubricious Double Pigtail Ureteral Stent Dated: September 30, 1998 Received: October 5, 1998 Regulatory Class: II 21 CFR 876.4620/Procode: 78 FAD

Dear Ms. Georgia:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compirance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION I - D

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bard Lubricious Ureteral Stent

Indications for Use:

The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use (Per 21 CFR 801.109)

،

Over The-Counter Use ____________________ OR

(Optional Format 1/2/96)

David L. Ingram

ivision Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number